KRIClass I

Accessory Equipment, Cardiopulmonary Bypass

21 CFR 870.4200 / Cardiovascular

KRI is the FDA product code for Accessory Equipment, Cardiopulmonary Bypass, a class I device type, regulated under 21 CFR 870.4200. As of 2026-09-10, FDA records hold 42 510(k) clearances under this code, the most recent dated 2002-05-03, and 8 recalls.

Classification record

Product code: KRI
Device name: Accessory Equipment, Cardiopulmonary Bypass
Regulation: 21 CFR 870.4200
Device class: Class I
Review panel: Cardiovascular
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 42
Ingested recalls: 8

Clearances, product code KRI

By decision year

42 clearances under product code KRI with a decision year between 1977 and 2002, 1981 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code KRI by decision year
Year	Clearances
1977	1
1978	2
1979	3
1980	1
1981	7
1982	2
1983	3
1984	3
1985	3
1986	5
1987	1
1988	2
1989	3
1992	1
1993	2
1999	2
2002	1

Applicants with the most clearances

Product code KRI

Applicants holding the most 510(k) clearances under product code KRI
Applicant	Clearances
American Bentley	7
Shiley, Inc.	4
Texas Medical Products, Inc.	3
American Omni Medical, Inc.	2
Bentley Laboratories, Inc.	2
Stoeckert Instrumente	2
3M Health Care, Sarns	1
3T Medical Systems Inc.	1
Acacia Laboratories, Inc.	1
Ammex Cardiopulmonary Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 40 companies shown, in name order